Quality Systems

Articles

Purisys is now certified for ISO 17025 for testing and calibration laboratories and ISO 17034 for reference material producers

Purisys Adds ISO Certifications 

The company is recalling one lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) after a glass particle was found in a vial.

Teva Recalls Product Due to Particulate Matter

Dr. Ulrich Kissel is chair of board of the European QP Association

David Cockburn is a board member of the European QP Association.

Despite some improved understanding of adapted processes in light of the pandemic, information is still not filtered throughout the qualified persons community fully and more work by authorities and associations is required to improve communications.

Survey of QPs on Remote Certification

Mark Rogers, PhD, mark.rogers@sgs.com, is the global scientific director for the SGS Health Science Drug Development group.

New challenges arise in extractable and leachable studies for cell and gene therapy products.

Preparing for the Unexpected: E&L Studies in Biopharma

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.

The Value of FDA 483s and Warning Letters

Editor of Pharmaceutical Technology Europe

Podcasts

Pharmaceutical Technology discussed the potential increased risk of counterfeit medicines in the UK post-Brexit and how blockchain could be a useful tool to tackle the issue.

Tackling Counterfeit Medicines

Thought and foresight into method development stages can ensure costly errors and delays are avoided later on.

Outlining the Key Steps to Method Development

Judith M. Sills, PharmD, is a nonexecutive director and advisor to Arriello—a provider of risk management and compliance services to the Life Sciences industry.

Eric Caugant is a nonexecutive director and advisor to Arriello—a provider of risk management and compliance services to the Life Sciences industry.

International pharmacovigilance for biotechs brings about a particular set of challenges, especially for small companies, which face the same rigour as large pharma companies.

Navigating International Pharmacovigilance

ISPE’s latest guide ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry focuses on how knowledge management allows for a more effective pharmaceutical quality system.

ISPE Releases New Knowledge Management Guide 

Developing and manufacturing a therapy in a regulated environment demands careful adherence to quality practices. 

Quality Assurance/Quality Control